Egrifta

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Egrifta

PATIENT INFORMATION

EGRIFTA™
(eh-GRIF-tuh)
(tesamorelin for injection) for subcutaneous use

Read the Patient Information that comes with EGRIFTA™ before you
start to take it and each time you get a refill. There may be new information.
This leaflet does not take the place of talking to your healthcare provider
about your medical condition or your treatment.

What is EGRIFTA™?

EGRIFTA™ is an injectable prescription medicine to reduce the excess
in abdominal fat in HIV-infected patients with lipodystrophy. EGRIFTA™
contains a growth hormone-releasing factor (GRF).

The impact and safety of EGRIFTA™ on cardiovascular health has not
been studied.

are breastfeeding or plan to breastfeed. It is not known if EGRIFTA™
passes into your breast milk. The Centers for Disease Control and Prevention
(CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk
of passing HIV infection to your baby. Talk with your healthcare provider
about the best way to feed your baby if you are taking EGRIFTA™

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. EGRIFTA™ may affect the way other medicines work, and other medicines may affect how EGRIFTA™ works.

Know the medicines you take. Keep a list with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I use EGRIFTA™ ?

Read the detailed "Instructions for Use" that comes with
EGRIFTA™ before you start using EGRIFTA™ . Your healthcare provider
will show you how to inject EGRIFTA™ .

Use EGRIFTA™ exactly as prescribed by your healthcare provider.

Inject EGRIFTA™ under the skin (subcutaneously) of your stomach area
(abdomen).

Change (rotate) the injection site on your stomach area (abdomen) with each
dose. Do not inject EGRIFTA™ into scar tissue, bruises or your navel.

Do not share needles or syringes with other people. Sharing of needles
can result in the transmission of infectious diseases, such as HIV.

What are the possible side effects of EGRIFTA™?

EGRIFTA™ may cause serious side effects including:

Serious allergic reaction. Some people taking EGRIFTA™ may
have an allergic reaction.

Stop using EGRIFTA™ and get emergency help right away if you have
any of the following symptoms:

a rash over your body

hives

swelling of your face or throat

shortness of breath or trouble breathing

fast heartbeat

feeling of faintness or fainting

Swelling (fluid retention). EGRIFTA™ can cause swelling in
some parts of your body. Call your healthcare provider if you have an increase
in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome).

Injection site reactions. Change (rotate) your injection site to
help lower your risk for injection site reactions. Call your healthcare provider
for medical advice if you have the following symptoms around the area of the
injection site:

redness

itching

pain

irritation

bleeding

rash

swelling

The most common side effects of EGRIFTA™ include:

joint pain

pain in legs and arms

swelling in your legs

nausea

vomiting

muscle soreness

tingling, numbness and pricking

rash

itching

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of EGRIFTA™ . For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. To report side effects, contact EMD Serono toll-free at 1-800-283-8088 ext. 5563. You may report side effects to FDA at 1-800-FDA-1088.

How do I store EGRIFTA™?

EGRIFTA™ has two boxes

Store the Medication Box of EGRIFTA™ vials in the refrigerator
between 2°C and 8°C (36°F and 46°F).

Store the box of Sterile Water for Injection, syringes and needles at
room temperature between 20°C to 25°C (68°F to 77°F).

Keep EGRIFTA™ vials in Medication Box away from light.

Do not freeze.

Do not use EGRIFTA™ after the expiration date printed on the carton
and vial labels.

After mixing, use EGRIFTA™ right away and throw away any unused EGRIFTA™
. Do not store mixed EGRIFTA™ . Also, throw away the used bottle of
Sterile Water for Injection.

Keep EGRIFTA™ and all medicines out of the reach of children.

General information about the safe and effective use of EGRIFTA™

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EGRIFTA™ for a condition for which it was not prescribed. Do not give EGRIFTA™ to other people, even if they have the same symptoms you have. It may harm them.

Do not share your EGRIFTA™ syringe with another person, even if the needle is changed. Do not share your EGRIFTA™ needles with another person.

This Patient Information leaflet summarizes the most important information
about EGRIFTA™. If you would like more information, talk with your healthcare
provider.

You can ask your healthcare provider or pharmacist for information about EGRIFTA™
that is written for healthcare professionals.

For more information about EGRIFTA™, go to www.EGRIFTA.com or contact
AXIS Center toll-free at 1-877-714-2947.

What are the ingredients in EGRIFTA™?

Active ingredient: tesamorelin

Inactive ingredients: mannitol and Sterile Water for Injection

Patient Instructions for Use

EGRIFTA™
(eh-GRIF-tuh)
(tesamorelin for injection) for subcutaneous use

Be sure that you read, understand, and follow these Patient Instructions for
Use before using EGRIFTA™. Your healthcare provider should show you how to
mix and inject EGRIFTA™ before you inject it for the first time. Ask your healthcare
provider if you have any questions.

Keep this leaflet in case you need to look at it again later.

Important information for use of EGRIFTA™

After mixing EGRIFTA™ with Sterile Water for Injection, it should
look clear and colorless, with no particles in it. Do not use EGRIFTA™
if it looks cloudy, discolored, or if you see particles in it. Talk to your
healthcare provider if you have any questions.

Do not use EGRIFTA™ after the date on the Medication Box and EGRIFTA™
vial.

Do not use a syringe or needle more than 1 time.

Do not share your EGRIFTA™ needles with another person. Sharing of
needles can result in the transmission of infectious diseases, such as HIV.
Do not share your EGRIFTA™ syringe with another person, even if the
needle is changed.

If you are missing any supplies from your Medication Box or Injection Box,
or if anything looks damaged call your pharmacist or contact AXIS Center toll-free
at 1-877-714-2947 right away.

A "sharps container" or a puncture resistant container for throwing
away needles after you are done with them. The container should be made from
hard plastic or metal. Make sure it has a lid. You can also put used syringes
or empty vials of medicine in the container.

Material included in Injection Box (a, b, c) and Medication Box (d):

Figure A

Step 3: Take out the following from your Injection Box:

A Sterile Water for Injection bottle (Figure A, a)

A syringe with needle already attached (Figure A, b)

A ½" 27-gauge injection needle with pink needle shield (Figure A,
c)

Step 4: Take one EGRIFTA™ vial (Figure A, d) from the Medication Box. Put the box with the remaining vials back in the refrigerator right away.

Take off the plastic caps from the vials of EGRIFTA™ and Sterile Water
bottle.

Clean the rubber stopper on top of the vial of EGRIFTA™ and Sterile
Water bottle with an alcohol swab.

How to mix EGRIFTA™

Step 1: Pick up the syringe with needle attached (Figure A, b), remove the
protective cap and insert the needle through the rubber stopper of the bottle
of Sterile Water (Figure A, a; see Figure B for illustration). Turn both upside
down, and pull back the plunger until the liquid reaches the 2.1 mL mark on
the syringe. (See Figure C)

Figure B

Figure C

Step 2: Take the syringe with needle attached out of the Sterile Water bottle
and insert the needle into the EGRIFTA™ vial. Push the plunger in slowly
on a slight angle so water goes down the inside wall of the EGRIFTA™ vial
instead of directly onto the powder to avoid foaming. (See Figure D)

Figure D

Step 3: While keeping the syringe with needle attached in the vial and the
vial upright, roll the vial gently in your hands for 30 seconds, until the Sterile
Water and EGRIFTA™ powder are mixed well. Do not shake the vial. (See Figure
E)

Figure E

Step 4: Still keeping the syringe with needle attached in the vial, turn both
until the syringe is straight up. Pull down on the syringe until you see just
the tip of the needle going through the rubber stopper, then pull back on the
plunger until all the liquid inside the vial goes into the syringe. The level
of medicine in the syringe should be around the 2.1 mL syringe mark. (See Figure
F)

Figure F

Step 5: Take the needle out of the vial. (See Figure G)

Figure G

Step 6: Place the needle cap on its side against a clean flat surface. Without
touching the needle, hold the syringe and slide the needle carefully into the
protective cap. (See Figure H) Push the cap all the way or until it snaps
shut (See Figure I). Do not touch the cap until it covers the needle
completely.

Figure H

Figure I

Step 7: With the cap on the needle, remove the needle by holding the syringe
firmly and twisting the cap counterclockwise (to the left). (See Figure J)

Figure J

Step 8: Place the injection needle (Figure A, c), with its white protective
cap in place, onto the syringe. Hold the syringe firmly and twist the cap clockwise
(to the right) until it closes securely. (See Figure K)

Figure K

Where do I inject EGRIFTA™?

You should inject EGRIFTA™ into the skin on your stomach (abdomen). (See Figure
L)

Pick an injection site that is around your belly button to the left or
right.

Stay away from any area with scar tissue, bruises, reddening, infection,
or irritation.

Change your injection site from one day to the next. This may help prevent
bruising or irritation. You may want to keep a note of the date and location
of each daily injection to help you remember.

Figure L

How to inject EGRIFTA™

Pick up the syringe and pull the cap straight off the injection needle.
Do not twist it. (See Figure M)

Figure M

Tap the syringe gently with your finger to force any air bubbles to rise
to the top. Press the plunger to push bubbles out. (See Figure N)

Figure N

Clean the injection site you have selected with an alcohol swab and let
it dry. Hold the syringe in one hand. Use your other hand to hold a cleaned
fold of skin for your injection. Hold the skin between your thumb and fingers.
(See Figure O)

Figure O

Hold the syringe at a right angle to the skin, like a dart. Push the injection
needle into the skin with a quick motion. Most of the needle should go beneath
the skin surface. (See Figure P)

Figure P

Remove your hand from the pinched area of skin after the needle goes in.
Make sure the needle stays in the skin. (See Figure Q)

Figure Q

Slowly push the plunger all the way down until all of the medicine in the
syringe has been injected under the skin.

Pull the injection needle out of your skin when the syringe is empty:

Be careful to pull it out at the same angle you put it in

Flip back the pink needle shield until it snaps, covering the injection
needle completely. Keep pressing until you hear a click, that means the injection
needle is protected. (See Figure R)

Figure R

Use a piece of sterile gauze to rub the injection site clean. If there is
bleeding, apply pressure to the injection site with gauze for 30 seconds.
If bleeding continues, apply a bandage to the site.

How should I dispose of the used syringes, needles, bottles and vials?

If you accidentally prick another person with a used needle, that person
should be informed to contact a healthcare provider right away about the accident.

Never reuse or recycle needles or syringes.

Never throw used needles, syringes, or the sharps container into the trash.

Throw away used syringes, needles, EGRIFTA™ vials and Sterile Water
for Injection bottle in a puncture-proof container, sharps container, or a
hard container like a coffee can.

Speak to your pharmacist or other healthcare provider about the proper disposal
of the sharps container and all other used materials. There may be local or
state laws about how to throw away used needles and syringes.

Keep the sharps container away from children and pets.

If you have any questions, call your healthcare provider. You can call
AXIS Center toll-free at 1-877-714-2947 or visit the EGRIFTA™ Web site
at: www.EGRIFTA™ .com for more information.

How do I store EGRIFTA™?

EGRIFTA™ has two boxes:

Store the Medication Box of EGRIFTA™ vials in the refrigerator between
2°C and 8°C (36°F and 46°F).

Store the Injection Box of Sterile Water for Injection, syringes and needles
at room temperature between 20ºC to 25ºC (68°F to 77°F).

Keep EGRIFTA™ vials away from light.

Do not freeze.

After mixing, use EGRIFTA™ right away and throw away any unused EGRIFTA™.
Do not store mixed EGRIFTA™. Also, throw away the used bottle of Sterile
Water for Injection.

Do not use EGRIFTA™ after the expiration date printed on the Medication
Box and vial labels.

Keep EGRIFTA™ and all medicines out of the reach of children.

Last reviewed on RxList: 12/12/2011
This monograph has been modified to include the generic and brand name in many instances.